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EP 0 874 657 B1 |
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EUROPEAN PATENT SPECIFICATION |
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Mention of the grant of the patent: |
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13.11.2002 Bulletin 2002/46 |
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Date of filing: 17.01.1997 |
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International Patent Classification (IPC)7: A61M 25/10 |
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International application number: |
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PCT/IT9700/010 |
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International publication number: |
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WO 9702/6040 (24.07.1997 Gazette 1997/32) |
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An isolated operating-room providing probe for the distal end of the oesophagus
Eine einen isolierten Operationsraum für das distale Ende der Speiseröhre erzeugende
Sonde
Système de champ opératoire isolé à sonde pour l'extrémité distale de l'oesophage
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Designated Contracting States: |
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AT BE CH DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE |
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Priority: |
19.01.1996 IT CE960001
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Date of publication of application: |
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04.11.1998 Bulletin 1998/45 |
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Proprietor: Paternuosto, Mario Immacolato |
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81100 Caserta (IT) |
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Inventor: |
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- Paternuosto, Mario Immacolato
81100 Caserta (IT)
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Representative: Sarpi, Maurizio |
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Studio FERRARIO
Via Collina, 36 00187 Roma 00187 Roma (IT) |
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References cited: :
WO-A-88/03389 DE-A- 3 915 289 US-A- 5 314 409
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DE-A- 3 640 034 US-A- 4 022 216
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| Note: Within nine months from the publication of the mention of the grant of the European
patent, any person may give notice to the European Patent Office of opposition to
the European patent
granted. Notice of opposition shall be filed in a written reasoned statement. It shall
not be deemed to
have been filed until the opposition fee has been paid. (Art. 99(1) European Patent
Convention).
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[0001] The present invention relates to the surgery field and, more particularly, a probe
which facilitates the execution, as an endoscopy, of a haemostasis (sclerosis or binding
of varices) in case of bleeding.
[0002] Sclerosing or binding the bleeding varices of the oesophagus is an operating endoscopy
which is executed on a hypovolaemic, often hyperammoniaemic patient markedly intolerant
of movements which are not directed to a determined end or controllable either. An
endoscopy should first locate the bleeding source and then carry out the operation
as quickly as possible because of the precarious patient's conditions. However, the
surgeon meets with a number of problems. First of all, administering a sedative to
such patients is dangerous. In addition, there is a continuous reflux of blood from
the gastric cavity to the operating area, represented by the distal end of the oesophagus,
which is caused by the eructation and the continuous retching produced by air insufflation,
water inlet and suction for clearing the operating area.
Under such conditions, both finding and treating the bleeding source need a lot of
time.
Furthermore, both perivaricose and intravaricose techniques are difficult since:
a) in the perivaricose technique, the needle point cannot always be controlled when
it softly pierces the oesophagus mucosa as the disappearance of the leading squirt
of blood cannot be seen while the wheal is formed;
b) in the intravaricose technique, which may be wrongly carried out while being convinced
that a perivaricose technique is executed, the injection of an excess of a sclerosing
agent may have a serious consequence.
[0003] US-A-5314409 discloses an esophageal perfusion catheter having an outer housing,
a plurality of flexible, tubular channel members within said housing, and two spaced
balloon members encompassing said catheter. Said esophageal perfusion catheter was
not designed neither for the emergency treatement of the bleeding varices of the oesophagus,
nor for any other endoscopic therapeutic treatment. Further, the aspiration holes
can easily be obstructed by the blood clots, in this way impeding the draining and
the cleaning of the operating room defined by the inflated balloons in the oesophagus.
[0004] DE-A-3640034, which is used as a basis for the preamble of claim 1, envisages the
introduction of an endoscope into a fenestrated tube sheath which is equipped with
two balloons that form a chamber.
The endoscope carries out the sclerosis on the variceal piles which result to be procidentiae
in the lumen of the tube itself and it allows suction of the haematic content from
the stomach through said fenestration.
It is easy to observe that given the technical conditions in which the work should
be carried out, it would indeed be rather cumbersome to carry out a ligature using
the device described in said document, which was conceived when ligature was carried
out using techniques which had not been sufficiently tested and refined.
[0005] According to the invention the above-mentioned problems and limits are overcome by
providing a probe having the characteristics recited in claim 1, which may be operated
by a different operator from that one operating the endoscopy and allows the operating
area to be isolated from the gastric cavity and the proximal end of the oesophagus
by inflating two pneumatic bladders. This allows the operation to be executed in several
more favourable circumstances: easier cleaning of the operating area from the considerable
quantity of blood through the suction channel which the device is provided with; blocking
of the reflux of the blood from the stomach to the oesophagus; prevention of the reflux
of the blood to the upper respiratory tract and reduction of ab ingestis pneumonias;
more effective suction of the blood in the gastric cavity; and keeping of a desired
pressure in the operating area.
[0006] Preferred embodiments of the probe are specified in the dependent claims.
[0007] It should be mentioned that the term proximal in the present description indicates
the segment or the tract of the outer side of the device located closer to the mouth.
In the same way the term distal will be used thereafter with the meaning that such
a term has in anatomy, i.e. that tract, element or end located away from a conventional
point of origin, that is the mouth in case of the alimentary canal.
The probe of the invention looks exteriorly like a tubular member of flexible material
having a circular cross section and connecting, at its distal end, two pneumatic inflatable
bladders at a suitable axial distance from each other, said bladders having different
forms and larger diameters than the tubular member which moreover divides, at its
proximal end, into two further tubular members of lower diameters.
The main tubular member is inside divided by partition walls into three channels,
two of which having circular cross sections and communicating with a respective bladder
which may be then inflated through the relative channel. The third channel is the
central main tubular member embracing the two minor channels and passing through the
bladders without communicating therewith.
In the length between the two bladders, the tubular member is provided with a plurality
of through holes providing a direct communication between the operating area and the
outside so as to prevent any increase in the pressure as a result of air insufflation
into the two bladders.
The length of the tubular member after the proximal bladder is completely closed and
carries a slidable coil provided with a small ring for hanging possible weights. Such
a length ends at the proximal end outside the mouth of the patient where, as mentioned
above, the tubular member divides into three tubular members. Actually, the two inner
channels, through which air can be insufflated into the bladders, separate from the
main tubular member outside the patient's mouth so as to form independent tubular
members having circular cross section and lumen lower than the main tubular member.
Thus, the intervention of side operators may be facilitated.
[0008] Further advantages and features of the probe of the present invention as well as
the method of use will be more readily apparent from the following detailed description
with reference to the accompanying drawings which show by way of a not limiting example
a preferred embodiment. In the drawings:
Fig. 1 shows schematically the device or probe as a whole;
Fig. 2 is a front view in enlarged scale of the two pneumatic bladders and the length
of the connecting tubular member;
Fig. 3 is a longitudinal section view of Fig. 2;
Fig. 4 is an enlarged detail of the length of tubular member about which the coil
is wound;
Figs. 5a and 5b are two sectioned views along the lines X-X' and Y-Y' of Fig. 2, respectively;
Fig. 6 shows schematically the probe used for providing an operating room in the oesophagus;
Fig. 7 shows schematically the probe used after the sclerosis for the suction of blood
in the gastric cavity;
Fig. 8 shows schematically a further step of suction of blood, the distal pneumatic
bladders being attached to pylorus.
[0009] With reference to the figures, the device or probe of the invention consists of a
composite, flexible tubular member which in a preferred embodiment has the length
of 180 cm and is formed of a pipe A-H of circular section which divides at F into
further two tubular members FG and FI having circular sections and reduced diameters.
Two pneumatic chambers or bladders BC and DE are located in the main tubular member
between A and F. Bladder BC is of natural rubber and, by way of example, has a width
of 1.5 cm, a length of 3 cm under deflated conditions and a six-radius-symmetry form
or other forms. It should be noted that such dimensions as well as those indicated
thereafter are not binding as they may be varied as a function of the operating conditions
and the particular patient. Also bladder DE is of natural rubber and, by way of example,
has a width of 2.5 cm, a length of 8 cm under deflated conditions and a circular section.
The length of the tubular member between the two bladders BC and DE is perforated.
The holes 10 of ellipsoidal form are preferably in a number of eight. As can be seen
from Figs. 2 and 3, the first two holes (major axis 7 mm, minor axis 3 mm) from bladder
BC are diametrically opposed but offset to each other by the same length as the major
axis. The other holes of the same dimensions are also diametrically opposed with parallel
major axes and offset to one another by a length as high as the double of their major
axis.
Advantageously, a first length of 5 cm from bladder BC of the tubular member between
bladders BC and DE has a colour which is different from that of the remaining pipe.
A slidable coil 12 provided with a ring 14 for hanging a possible weight 16 allowing
a fixed subcardias traction, as shown in Fig. 6, is provided along the tubular member
between bladder DE and point F (Fig. 4).
[0010] The length between point A and bladder BC is provided with a crossing hole 18 of
2 mm diameter, ends in a round form and has a length of 1 cm (Fig. 2).
[0011] The inner structure of the probe is now described with reference to the longitudinal
section of Fig. 3. The length of pipe between point A and point B has no lumen. The
length of pipe from point B to point F has a wall thickness of 0.5 mm and an inner
diameter of the larger main channel, indicated at 4 and including two further channels
6 and 8, of 3 mm. Channels 6 and 8 have a lumen of 1 mm and are located in parallel
on either inner side of the main channel 4 at the same distance from the centre thereof.
Preferably, channels 6 and 8 have a length which is different from that of channel
4. Channel 8 has the function of insufflating air into bladder DE through four holes
19 of 2 mm diameter. The other channel 6 has the function of insufflating air into
bladder BC through two holes 20 of 2 mm diameter. The two channels 6 and 8 are closed
at their initial ostium by plugs integral therewith 22, 24, respectively (Fig. 1).
[0012] The length F-H of the tubular member has at its proximal end (point H) a flared terminal
23.
[0013] According to a preferred embodiment the probe is made of thermoplastic material except
for the bladders which are of natural rubber.
[0014] The method of use is now described with reference to the three following execution
steps or times.
1) Oesophagus Time
[0015] After the introduction of the probe through the patient's mouth, the gastric cavity
is isolated from the oesophagus tract by inflating the distal bladder BC. Thereafter
the operator introduces the endoscopy into the operating area by slipping it along
the side of the proximal, still deflated bladder DE. Thus, upon inflating with air
the latter bladder, the proximal tract of the oesophagus is isolated from the operating
area 26 where the endoscopy carries out the sclerosis (Fig. 6). Operating area 26
communicates with the outside through the holes 10 of the main tubular member 4, which
prevents any increase in the pressure caused by air insufflation into the probe. The
same holes 10 are also used for continuously cleaning the operating area: any liquid
inlet may either be sucked through such holes 10 or through the channel of the endoscopy
(not shown in the figures).
[0016] The advantages of the method according to the invention are as follows:
a) neither air nor water inlet into the stomach so as to reduce the risk of reflux
which is, however, made impossible by the bladder closing the cardias, as shown in
Fig. 6;
b) prevention of an ingestis pneumonia, which is a very serious trouble in such patients,
by the presence of the proximal bladder in the oesophagus so as to form a cover for
the operating area (Fig. 6). It should be mentioned that such an event is rather frequent
as the reflection of the cough is turbid: the patient is wasted and hyperammoniaemic
and, in most cases, has taken a sedative;
c) compression of the varices in two points so as to reduce the risk of a pulmonary
embolus. Such a circumstance is greatly appreciated when the actuation of a perivaricose
technique, upon eradicating, is very difficult because of fibrosis due to preceding
interventions. Under such conditions, the wall of the oesophagus may be sclerosed
with the risk of possible complications if the perivaricose technique is carried out
repeatedly;
d) elimination of the problem due to the conveyance of the diluted blood towards pylorus
due to the washing of the operating area with water, thus avoiding the risk of coma;
e) considerable facilitation of the binding technique when the varices are being broken,
which is very difficult because of the considerable quantity of blood limiting the
field of sight already limited by the binding equipment, since in case of emergency
sclerosis or binding the serious problem of cleaning the operating area is overcome
in a very short time. This is due to the fact that cleaning and washing are devolved
on another operator acting in cooperation with but independently of the first operator
who manages the endoscopy;
f) continuous presence of the operating needle in the operating channel in case of
emergency sclerosis as the cleaning and the suction are carried out by the probe of
the invention.
2) Gastric Time
[0017] After the sclerosis, the probe is removed by deflating the two bladders and its slotted
part is brought to the best possible position for the suction of blood by means of
a polypus loop or biopsy pliers, as shown in Fig. 7. However, some absolutely not
removable coagulation generally remains so that the third step, i.e. the Duodenal
Time, is required.
3) Duodenal Time
[0018] The distal bladder is positioned (Fig. 8) in the bulb by means of biopsy pliers or
a loop engaging the towing cable of the probe and then it is attached to pylorus by
a suitable insufflation. This is the only way to remove at best blood and coagulation
because of the strategic position of the distal bladder in the bulb and the provision
of the holes allowing washing and suction during the 24 hours.
1. A probe which facilitates the execution of haemostasis techniques in case of bleeding
varices of the oesophagus formed of a composite, flexible device of tubular form crosswise
divided into three channels (4, 6, 8) and provided at its distal end with two bladders
(BC, DE) placed at an axial distance from each other and inflatable independently
of each other by air insufflated through two respective channels (6, 8) so that, upon
inflating said two bladders (BC, DE), it is possible to isolate the axial length between
the two bladders from the gastric cavity and the proximal tract of the oesophagus,
thus forming an isolated operating room (26) at the distal end of the oesophagus,
said operating room (26) being always kept in communication with the outside through
the channel (4) which is not connected to said bladders (BC, DE); one of said three
channels (4, 6, 8) having a larger diameter and including the other two channels of
like lower diameters, said channel (4) of larger diameter being provided with through
holes (10) in the length between said bladders (BC, DE) for establishing a direct
communication between the probe and the outside, each channel (6, 8) of lower diameter
being connected to the respective one of the two bladders (BC, DE), characterized in that the proximal bladder (DE) has a length of 8 cm and a circular section of 2.5 cm diameter
under deflated conditions, while the distal bladder (BC) has a length of 3 cm and
a diameter of 1.5 cm under deflated conditions; the holes (10) of the channel of larger
diameter (4) positioned between the two bladders (BC, DE) are in a number of eight,
have an ellipsoidal form with major axis parallel to the axis of the channel, and
are placed in four pairs in diametrically opposed positions along the periphery of
the larger channel apart from the channels of lower diameter; the channels of lower
diameters communicate with the respective bladders (BC,DE) through holes (19,20),
which are in a number of four in the proximal bladder (DE) and in a number of two
in the distal bladder (BC), said holes (19, 20) being circular with a diameter of
2 mm and being located at a distance of 14 mm from one another in series along only
one part of the periphery of the relative channel (6, 8).
2. The probe of claim 1, wherein it has a length of about 180 cm, a wall thickness of
0.5 mm, an inner diameter of the larger channel (4) of 3 mm, an inner diameter of
the lower channels (6, 8) of 1 mm.
3. The probe of claim 1, wherein said tubular structure is of any thermoplastic material
except for the bladders (BC, DE) which are of natural rubber.
4. The probe of claim 1, wherein the first two holes (10) closer to the distal bladder
(BC) are diametrically opposed and offset to each other by the same length as their
major axis, while the remaining holes (10) are offset to one another by a length as
high as the double of their major axis.
5. The probe of claims 1 and 4, wherein the length of the major axis of said holes (10)
is 7 mm and that of the minor axis is 3 mm.
6. The probe of claim 1, wherein the channels (6, 8) of lower diameters forme tracts
passing within said bladders (BC, DE) wherby said circular holes (19,20) are arranged
in the respective tracts.
7. The probe of claim 1, wherein one (BC) of the two bladders is located at the distal
end of the probe and has dimensions lower than those of the other bladder (DE), that
is located at a proximal position with respect to the former and has elongated form
and circular section.
8. The probe of claims 1 and 7, wherein the distances of the proximal end and the distal
end of the longer bladder (DE) from the end of the probe are 23.9 cm and 16 cm, respectively,
while the distances of the proximal end and the distal end of the shorter bladder
(BC) from the end of the probe are 4 cm and 1 cm, respectively, and the distance between
the two bladders (BC, DE) is 12 cm.
9. The probe of claim 1, wherein the two lower channels (6, 8) are divided from the larger
channel (4) at the proximal end of the probe by a length of 25 cm and are provided
each with a plug (22, 24) integral therewith.
10. The probe of claim 1, wherein the larger channel (4) is flared (23) at its proximal
end (H).
11. The probe of claim 1, wherein the portion of the probe with the through holes (10)
closer to the distal bladder (BC) has a different colour by a length of some centimetres.
12. The probe of claim 1, wherein the section of the larger channel (4) from the distal
bladder (BC) to the end point (A) of the probe is solid, has a length of 1 cm and
is provided with a through hole (18) of a few millimetre diameter.
13. The probe of claim 1, wherein it is provided with a coil (12) which is wound about
a length (FE) of the probe and provided with a ring (14) to which a weight (16) allowing
a fixed subcardias traction may be hung.
14. The probe of claim 1, wherein the proximal bladder (DE) under deflated conditions
is such as to allow the operator to slip an endoscope to the operating area.
1. Sonde zur leichteren Durchführung von Hämostasetechniken bei Varizenblutungen im Ösophagus,
bestehend aus einer zusammengesetzten, flexiblen Vorrichtung röhrenförmiger Gestalt,
die in Querrichtung in drei Kanäle (4, 6, 8) unterteilt und an ihrem distalen Ende
mit zwei Blasen (BC, DE) versehen ist, die im axialen Abstand voneinander angeordnet
und mittels Luft, die durch zwei Kanäle (6, 8) eingeblasen wird, unabhängig voneinander
aufblasbar sind, so dass es beim Aufblasen der beiden Blasen (BC, DE) möglich ist,
die axiale Länge zwischen den beiden Blasen von der Magenhöhle und dem proximalen
Trakt das Ösophagus zu isolieren und so einen isolierten Operationsraum (26) am distalen
Ende des Ösophagus zu bilden, wobei der Operationsraum (26) über den Kanal (4), der
nicht mit den Blasen (BC, DE) verbunden ist, stets mit der Außenseite in Verbindung
bleibt, wobei einer der drei Kanäle (4, 6, 8) einen größeren Durchmesser aufweist
und die anderen beiden Kanäle mit den entsprechend kleineren Durchmessern enthält,
wobei der Kanal (4) mit dem größeren Durchmesser mit durchgehenden Löchern (10) in
der Länge zwischen den Blasen (BC, DE) zum Herstellen einer direkten Verbindung zwischen
der Sonde und der Außenseite versehen ist, wobei jeder Kanal (6, 8) mit kleinerem
Durchmesser mit einer der beiden Blasen (BC, DE) verbunden ist, dadurch gekennzeichnet, dass die proximale Blase (DE) eine Länge von 8 cm und einen kreisförmigen Abschnitt mit
einem Durchmesser von 2,5 cm unter Deflationsbedingungen aufweist, während die distale
Blase (BC) eine Länge von 3 cm und einen Durchmesser von 1,5 cm unter Deflationsbedingungen
aufweist, die zwischen den beiden Blasen (BC, DE) angeordneten Löcher (10) im Kanal
mit dem größeren Durchmesser (4) in einer Anzahl von acht Löchern vorliegen, eine
ellipsoide Form mit der Hauptachse parallel zur Achse des Kanals aufweisen und in
vier Paaren sich diametral gegenüberliegend auf dem Umfang des größeren Kanals im
Abstand von den Kanälen mit kleinerem Durchmesser angeordnet sind, die Kanäle mit
dem kleineren Durchmesser mit den jeweiligen Blasen (BC, DE) über Löcher (19, 20)
in Verbindung stehen, die in einer Anzahl von vier Löchern in der proximalen Blase
(DE) und in einer Anzahl von zwei Löchern in der distalen Blase (BC) angeordnet sind,
wobei diese Löcher (19, 20) kreisförmig sind, einen Durchmesser von 2 mm aufweisen
und im Abstand von 14 mm voneinander in Reihe entlang nur eines Teils des Umfangs
des jeweiligen Kanals (6, 8) angeordnet sind.
2. Sonde nach Anspruch 1, worin die Sonde eine Länge von ca. 180 cm, eine Wanddicke von
0,5 mm, einen Innendurchmesser des größeren Kanals (4) von 3 mm und einen Innendurchmesser
der kleineren Kanäle (6, 8) von 1 mm aufweist.
3. Sonde nach Anspruch 1, worin die röhrenförmige Konstruktion aus einem beliebigen thermoplastischen
Material besteht, mit Ausnahme der Blasen (BC, DE), die aus Naturkautschuk bestehen.
4. Sonde nach Anspruch 1, worin die ersten, der distalen Blase (BC) näher liegenden,
beiden Löcher (10) sich diametral gegenüberstehen und über die Länge ihrer Hauptachse
gegeneinander versetzt sind, während die restlichen Löcher (10) über eine Länge, die
doppelt so lang sein kann wie ihre Hauptachse, gegeneinander versetzt sind.
5. Sonde nach Anspruch 1 und 4, worin die Länge der Hauptachse der Löcher (10) 7 mm und
die Länge der Nebenachse 3 mm betragen.
6. Sonde nach Anspruch 1, worin die Kanäle (6, 8) mit kleinerem Durchmesser innerhalb
der Blasen (BC, DE) verlaufende Gänge bilden, wodurch die kreisförmigen Löcher (19,
20) in den jeweiligen Gängen angeordnet sind.
7. Sonde nach Anspruch 1, worin eine (BC) der beiden Blasen am distalen Ende der Sonde
angeordnet ist und kleinere Abmessungen aufweist als die andere Blase (DE), die proximal
relativ zur ersten Blase angeordnet ist und eine längliche Gestalt und einen kreisförmigen
Querschnitt aufweist.
8. Sonde nach Anspruch 1 und 7, worin die Abstände des proximalen Endes und des distalen
Endes der längeren Blase (DE) vom Ende der Sonde 23,9 cm bzw. 16 cm betragen, während
die Abstände des proximalen Endes und des distalen Endes der kürzeren. Blase (BC)
vom Ende der Sonde 4 cm bzw. 1 cm betragen, und der Abstand zwischen den beiden Blasen
(BC, DE) 12 cm ist.
9. Sonde nach Anspruch 1, worin die beiden kleineren Kanäle (6, 8) vom größeren Kanal
(4) am proximalen Ende der Sonde über eine Länge von 25 cm getrennt sind und jeweils
mit einem einstückig damit geformten Pfropf (22, 24) versehen sind.
10. Sonde nach Anspruch 1, worin der größere Kanal (4) an seinem proximalen Ende (H) aufgeweitet
ist (23).
11. Sonde nach Anspruch 1, worin der, der distalen Blase (BC) näher liegende Abschnitt
der Sonde mit den durchgehenden Löchern (10) über einige zentimeter eine andere Farbe
aufweist.
12. Sonde nach Anspruch 1, worin der Abschnitt des größeren Kanals (4) von der distalen
Blase (BC) bis zum Endpunkt (A) der Sonde fest ist, eine Länge von 1 cm aufweist und
mit einem durchgehenden Loch (18) mit einem Durchmesser von einigen wenigen Millimetern
versehen ist.
13. Sonde nach Anspruch 1, worin die Sonde mit einer Spule (12), die über eine Länge (FE)
der Sonde gewickelt ist, und mit einem Ring (14) versehen ist, an dem ein Gewicht
(16) zum Aufhängen eines festen Subkardia-Zugs befestigt werden kann,
14. Sonde nach Anspruch 1, worin die proximale Blase (DE) es dem Chirurg unter Deflationsbedingungen
gestattet, ein Endoskop zum Operationsraum zu schieben.
1. Sonde qui facilite l'exécution des techniques hémostatiques dans le cas de varices
hémorragiques de l'oesophage, formée d'un dispositif flexible composite, de forme
tubulaire, divisé dans le sens de la largeur en trois canaux (4, 6, 8) et pourvu à
son extrémité distale de deux poches (BC, DE) placées à une distance axiale l'une
de l'autre et gonflable indépendamment l'une de l'autre par insufflation d'air à travers
deux canaux respectifs (6, 8) de telle sorte que, lors de l'insufflation desdites
deux poches (BC, DE), il est possible d'isoler la longueur axiale entre les deux poches
à partir de la cavité gastrique et du tractus proximal de l'oesophage, formant ainsi
un champ opératoire isolé (26) à l'extrémité distale de l'oesophage, la communication
entre ledit champ opératoire (26) et l'extérieur étant toujours maintenue à travers
le canal (4) qui n'est pas connecté auxdites poches (BC, DE) ; l'un desdits trois
canaux (4, 6, 8) ayant un diamètre supérieur et comprenant deux autres canaux de diamètres
inférieurs égaux, ledit canal (4) de diamètre supérieur étant pourvu de trous débouchants
(10) dans la longueur entre lesdites poches (BC, DE) pour établir une communication
directe entre la sonde et l'extérieur, chaque canal (6, 8) de diamètre inférieur étant
connecté à l'une respective des deux poches (BC, DE), caractérisée en ce que la poche proximale (DE) a une longueur de 8 cm et une section circulaire de 2,5 cm
de diamètre en état dégonflé, alors que la poche distale (BC) a une longueur de 3
cm et un diamètre de 1,5 cm en état dégonflé, les trous (10) du canal de diamètre
supérieur (4) positionné entre les deux poches (BC, DE) sont au nombre de huit, ont
une forme ellipsoïdale avec le grand axe parallèle à l'axe du canal, et sont placés
en quatre paires dans des positions diamétralement opposées le long de la périphérie
du canal le plus grand à l'écart des canaux de diamètre inférieur; les canaux de diamètre
inférieur communiquent avec les trous débouchants (19, 20) des poches respectives
(BC, DE), trous qui sont au nombre de quatre dans la poche proximale (DE) et au nombre
de deux dans la poche distale (BC), lesdits trous (19, 20) étant circulaires avec
un diamètre de 2 mm et étant situés à une distance de 14 mm les uns des autres en
série le long d'une seule partie de la périphérie du canal respectif (6, 8).
2. Sonde selon la revendication 1, dans laquelle elle a une longueur d'environ 180 cm,
une épaisseur de paroi d'environ 0,5 mm, un diamètre interne du canal le plus grand
(4) de 3 mm, un diamètre interne des canaux les plus petits (6, 8) de 1 mm.
3. Sonde selon la revendication 1, dans laquelle ladite structure tubulaire est fabriquée
dans un matériau thermoplastique quelconque, excepté les poches (BC, DE) qui sont
en caoutchouc naturel.
4. Sonde selon revendication 1, dans laquelle les deux premiers trous (10) les plus proches
de la poche distaie (BC) sont diamétralement opposés et décalés les uns des autres
de la même longueur que leur grand axe, alors que les trous restants (10) sont décalés
les uns par rapport aux autres d'une longueur équivalente au double de leur grand
axe.
5. Sonde selon les revendications 1 et 4, dans laquelle la longueur du grand axe desdits
trous (10) est de 7 mm et celle du petit axe est de 3 mm.
6. Sonde selon la revendication 1, dans laquelle les canaux (6, 8) de diamètres inférieurs
forment des conduits passant à l'intérieur desdites poches (BC, DE), moyennant quoi
lesdits trous circulaires (19, 20) sont agencés dans les conduits respectifs.
7. Sonde selon la revendication 1, dans laquelle l'une (BC) des deux poches se situe
à l'extrémité distale de la sonde et a des dimensions inférieures à celles de l'autre
poche (DE), qui est située à une position proximale par rapport à la première et a
une forme allongée et une section circulaire.
8. Sonde selon les revendications 1 et 7, dans laquelle l'extrémité proximale et l'extrémité
distale de la poche la plus longue (DE) sont, à partir de l'extrémité de la sonde,
distants respectivement de 23,9 cm et 16 cm, alors que l'extrémité proximale et de
l'extrémité distale de la poche la plus courte (BC) sont, à partir de l'extrémité
de la sonde, distants respectivement de 4 cm et de 1 cm, respectivement, et la distance
entre les deux poches (BC, DE) est 12 cm.
9. Sonde selon la revendication 1, dans laquelle les canaux les plus petits (6, 8) sont
séparés du canal le plus grand (4) à l'extrémité proximale de la sonde par une longueur
de 25 cm et sont chacun pourvus d'un bouchon (22, 24) faisant partie intégrante de
ceci.
10. Sonde selon la revendication 1, dans laquelle le canal le plus grand (4) est évasé
(23) à son extrémité proximale (H).
11. Sonde selon la revendication 1, dans laquelle la portion de la sonde ayant les trous
débouchants (10) la plus proche de la poche distale (BC) a une couleur différente
sur une longueur de quelques centimètres.
12. Sonde selon la revendication 1, dans laquelle la section du canal le plus grand (4)
à partir de la poche distale (BC) jusqu'au point d'extrémité (A) de la sonde est solide,
a une longueur de 1 cm et est pourvue d'un trou débouchant (18) de quelques millimètres
de diamètre.
13. Sonde selon la revendication 1, dans laquelle elle est pourvue d'une spirale (12)
qui est enroulée autour d'une longueur (FE) de la sonde et est pourvue d'un anneau
(14) auquel un poids (16) permettant une traction sous-cardiale fixe peut être suspendu.
14. Sonde selon la revendication 1, dans laquelle la poche proximale (DE) en état dégonflé
est telle qu'elle permet à l'opérateur de faire glisser un endoscope dans le champ
opératoire.